BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 5488533 · Received March 9, 2016

    Report

    Report Number
    0001032347-2016-00125
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Report Date
    February 10, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PARTS REPORTED FOR THIS EVENT WERE RETURNED AND EVALUATED FOR THE COMPLAINT THAT THE TIPS HAVE BROKEN. BASED ON THE PRODUCT EVALUATION, THE COMPLAINT FOR THIS PART AND LOT WAS CONFIRMED WITH A BROKEN TIP. BASED ON THE PRODUCT EVALUATION, THE MOST-LIKELY UNDERLYING CAUSE OF THE COMPLAINT WAS DETERMINED TO BE THE EXCESSIVE FORCE EXPERIENCED DURING USE OUTSIDE OF THE INTENDED USE. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT 2 OF 4 FOR THE SAME EVENT. REPORTS 1, 3, AND 4 ARE REPORTED ON MFR #0001032347-2016-00053-2, 0001032347-2016-00126-1, AND 0001032347-2016-00127-1.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE PRODUCT EVALUATION. REPORT TWO OF FOUR FOR THE SAME COMPLAINT; SEE ALSO 0001032347-2016-00053-1, 00125, 00126 AND 00127.

    Description of Event or Problem · 1

    THE FACILITY REPORTED FOUR (4) 301 ELEVATORS BROKE AT THE TIP DURING FOUR DIFFERENT PROCEDURES. THE DATES AND SPECIFIC CASE DETAILS WERE UNABLE TO BE PROVIDED, HOWEVER IT WAS CONFIRMED THAT ALL PARTS OF THE INSTRUMENTS WERE RETRIEVED AND NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145255 ELEVATOR #301 ELEVATOR EMJ BIOMET MICROFIXATION N/A 052714E14

    Patients

    Seq Age Sex Outcome Treatment
    1